Electronic records

Subpart B – Electronic Records
§11.10 - Controls for Closed Systems
Requirements
Application notes
Procedure links
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to assist with the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to help confirm that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:
§11.10, section a
Validation of systems to assist with accuracy,reliability, consistent intended performance, and the ability to discern invalid or altered records.
The system validation is a unique process and lies with the customer.
Rockwell Automation can provide validation services for any validation activity performed during the specific integration of the system.
The implementation of any measures aimed at meeting this requirement lies with the customer.
§11.10, section b
The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding theability of the agency to perform such review and copying of the electronic records.
FactoryTalk Optix Studio can store data records for alarms, audits, and process data into an external database. Alternatively, data records can be stored into an internal (embedded) database, but consideration should be given as to database limitations.
NOTE: Refer to
§11.10, section c
 for more information.
For enhanced detectability, alarming and logic can be implemented to prevent the user from entering data in the event the network connection from FactoryTalk Optix Studio to the database is lost.
Once data has been sent to the database, users can employ FactoryTalk® Optix objects and nodes, developed libraries, and custom NetLogic methods to read records, including data visualization, exports, reporting. Query based datalogging and reporting are both supported. FactoryTalk Optix Studio provides reporting features.
§11.10, section c
Protection of records to enable their accurate and ready retrieval throughout the records retention period.
Records can be stored in an external database, as described in 11.10, section b. Alternatively, data records can be stored into an internal (embedded) database, but consideration should be given as to the location where the runtime is deployed, the size of storage space, and database record limits. For most applications, it may be preferred to store data records to a dedicated external database for adherence to data retention policies and disaster recovery procedures
Records can be made available for viewing, printing, and exporting during the records retention period.
Precautionary measures such as periodic backup of the database are procedures that customers should incorporate into their SOP. Access to these databases should be controlled to maintain data integrity. For external databases, these are managed by the database administrator. For internal databases, automatic backup can be set up through tag-based controller variables or C# script, and access to the internal database is managed by securing the runtime location hardware and software. Both the backup and restoring features can be used independently from the database type.
When saving application files for backup and version control, FactoryTalk Optix provides options to save to a local or remote repository. Preference may be given to use of a local repository managed by an administrator for data security.
While there is no buffering or caching of audit messages in the local system, alternative methods can be employed to enable data integrity, such as through installation of MQTT with NetLogic. Additionally, if the network connection to FactoryTalk Optix Studio is lost, specifically customized logics can be implemented to prevent the user from entering data until a connection is restored.